Temperature controlled logistics is imperative for many pharmaceutical products, as spoiled drugs can have serious consequences on the health and well being.

What is temperature controlled logistics?

Temperature controlled logistics specializes in the storage, preservation and transportation of cargo that is sensitive to atmospheric conditions and needs to maintain a certain temperature. This is imperative for many pharmaceutical products, as spoiled drugs can have serious consequences on the health and wellbeing.

Elevated temperatures or sub-zero temperature can affect the chemical stability of the medicine and may even alter its physical properties. This can come in the form of sedimentation and separation of emulsion systems.

Due to the implications of improperly stored drugs, regulator demands have become more stringent and pharmaceutical companies need to be able to prove that they’re products are transported via a temperature controlled supply chain.

The margin of error is different from product to product, but the industry has seen a greater regulatory emphasis on drugs that can maintain integrity between 2 º C and 8ºC. This temperature range is referred to as “cold-chain” – a temperature range where the medicine is maintained above sub-zero temperatures. These conditions must be assured by all parties, including the manufacturer, shipper, and wholesaler.

While the shipping services are responsible for maintaining the temperature of the cargo, it is the manufacturer’s responsibility to ensure the optimal conditions for the product are understood by all involved parties. Some considerations to think about before choosing a temperature controlled solution.

The acceptable temperature and humidity range

The margin of error for the temperature

Acceptable levels of risk

Potential areas of risk and touch points

Specific no-go actions that may compromise the integrity of the product

Additional conditions for selecting a cold storage system should be based, but not limited to, the following criteria:

The temperature range and volume of the medicine

Temperature controls

Back up temperature controls

The layout of the storage unit and airflow

External temperature logging and data tracking

Cargo placement (avoid areas where temperature variation is likely such as near bay doors)

Others argue that the biggest consideration when choosing transport for pharmaceutical logistics is the risk to the end-user if there is a delay or problem with the shipment. Either way, thorough risk assessments are necessary when selecting a suitable mode of transport and considerations must be made about the costs of replacing the product if something were to go wrong.

What are the critical touchpoints?

Logistics is complex, dynamic and ever-changing. As such, there is a wide array of touchpoints and hand-off processes between the various actors involved with the distribution of the product. As such, it is imperative that areas of risk are understood to ensure the proper handling of medicines.

Different medicines and different transportation methods will come with their own unique touch points, but here is a rundown of the most common touchpoints that pose a risk to your medicine.

Preparing the product for transport to the shipper location – The primary transportation method may have temperature controlled storage facilities, but does the warehouse the product is stored in prior to transportation have similar facilitiesTransportation to the shipper location – Refrigerated vehicles or passive cooling systems will have to be considered to ensure the drugs will not be compromised en-route. Similarly, once the product reaches the shipper's storage facilities, will it have the required apparatus to ensure the safety of your medicines.

Minimizing the amount of time the drugs spend at ambient temperatures is critical, especially in warmer climates. Walk-in cold storage rooms or dry ice can be used to help maintain the temperature of active and passive containers.Physical loading – Ramp handling, covered storage, and potential delays need to be accounted for. Additionally, if an electrical connection to power is required, do all of the touch points have a compatible connection and ability to output appropriate wattage?

During transit - Finally, once the product is in the cargo hold of the aircraft or vessel – is it being sufficiently protected? The temperature controls may have been taken care of, but the positioning of the cold storage unit is just as important. Avoid storing the medicine near cargo doors and other cargo in general. Adequate circulation around the product is often required to reach a stabilized temperature. A notice to the captain should be issued to ensure that all variables are taken care of.

Furthermore, it is important to ensure cooling apparatus remains active for the duration of the transit. Mistakes can come in the form of energy saving modes being turned on without notice, and cooling apparatus being switched off during rest periods.

Standards and regulations

Companies operating within the pharmaceutical cold chain must be aware of the latest rules and standards in the market. Due to the complexity of transporting drugs internationally, keeping up to date can be a daunting task. Some countries may even have safety regulation that involves physically opening and inspecting cargo, which can result in temperature deviations. It is good practice to make data and temperature loggers accessible from outside of the storage container to keep opening containers to a minimum.

In the EU, the Directive 2001/83/EC is the foremost legal document with regards to governing the production, distribution and use of medicinal products. Find the full document here.

In addition, regulations are routinely published in the following groups:

Types of temperature controlled logistics

Refrigerated vehicles - This category includes conventional vehicles that have thermostatically controlled cargo compartments, enabling the temperature range to be maintained. Refrigerated vehicles often come in the form of small vans and trucks, which are often equipped with electronic control systems to manage temperature. While some vehicles in the category rely on the engine to supply power to the refrigeration unit, larger vehicles have independently powered units and electrical backups.

Passive shipping container - Passive shipping systems are storage containers that utilize a combination of insulating materials and electronics to maintain a temperature range. While they do not require human or external input to function, they can only maintain a temperature range for a set period of time before they expire, making them an effective option for short journeys. Impact resistant - these containers are often necessary to mitigate any potential damage to the transported cargo, making them necessary for road transportation. Passive shipping systems are often used alongside the other major types of temperature controlled logistics for an additional layer of protection.

Active shipping system – These are similar to passive shipping containers but are much larger in scope. Active shipping systems are used aboard airfreight and sea freight shipping – and are effectively large thermostatically controlled cargo containers. On air freight, they are typically powered via internal batteries or an external electrical source and maintain power via large cooling fans and heating mechanisms. Meanwhile, sea freight active shipping systems are generally powered by the ships onboard power supply.

Check out this World Health Organization manual for more detailed guidance on temperature-controlled transport

Capacity oversupplyOvercapacity has created a more competitive service for manufacturers and as a result, services have become more temperature-controlled pharmaceutical focused, which is positive for the quality of the products.

Weak PointsIt is widely acknowledged that the weakest points in the air freight supply chain are the transfer points between the different players. Staff training, increased planning for the aircraft type and increased due diligence are areas that require more attention.

Cost efficiencyA key element of cost-saving and efficiency in the air freight industry is modernisation and the use of technology for process improvement and optimisation. Like other industries, pharma logistics companies face the challenge of incorporating digitisation, despite the cargo industry not being technology driven.

The future of air freightWith the demise of huge blockbuster drugs hitting the market every couple of years, the generics industry now covers a large proportion of the generic medicines that are being delivered to patients. transportation methods will be approached in a far more cost-conscious manner in the years to come.

What are the types of air freight

Commercial Airlines –Commercial airlines tend to primarily transport passengers, but most offer cargo services to take advantage of the airport to airport destinations. However, commercial airlines tend to have smaller storage capacity in comparison to dedicated cargo airliners. In addition, cold storage apparatus will likely be retrofitted within the airliner and hired from a third-party company, as opposed to being an innate feature of the airliner. Co-ordination will be balanced between a freight forwarding agent and the airliner.

Integrators – Integrators refer to dedicated mail delivery services such as DHL and UPS. These companies will coordinate directly with airlines to ensure the optimal delivery of the drugs.Specialized cargo airliners -Cargo only aircraft do not carry passengers and have substantially more room for cargo as a result.

Sea freight temperature controlled logistics

In the last few years, the price of air freight has been on an incline; as a result, pharmaceutical companies all over the world are looking for alternative cost-effective methods of transporting their life sciences products. Sea freight is the major alternative and is becoming increasingly more viable in comparison to air freight.

Less risky - Sea freight offers a more controlled environment in comparison to air freight. There are fewer control points and disruptions, as sea freight cargo will not be touched until it reaches its destination.

Easier to monitor - Sea freights are continuously improving, and most services offer real-time tracking and monitoring – further reducing the risk factor.

Fewer temperature excursions - This provides an unbroken cold chain and less exposure to ambient temperatures.

Management –You need to manage your lead times and processes. Take them both into consideration.

Airfreight or sea freight?

Adam Tetz Peli BioThermal’s director of worldwide marketing said: “There will always be a need for air transportation when emergencies arise and there is the need to get products shipped more quickly."As regulators introduce tighter rules around transport and logistics, and more temperature-sensitive medicines enter the market, the gap between air and sea transportation will narrow. However, it will not make other forms of transportation redundant.

Some pharma products will always be in high demand or have a high enough value to only travel by air. There will always be emergencies and natural disasters that need pharmaceuticals quickly. Shipments sent over the water could be unavailable for four to six weeks, so air transport will be a valuable logistics mode when speed is called for.

Subscribe to our Free Newsletter

We respect your privacy, by clicking ‘SUBSCRIBE’ you agree to receive our e-newsletter, including information on Podcasts, Webinars, event discounts and online learning opportunities. For further information on how we process and monitor your personal data click here. You can unsubscribe at anytime.

FIND CONTENT BY TYPE

Pharma Logistics COMMUNITY

ADVERTISE WITH US

Reach Pharma Logistics professionals through cost-effective marketing opportunities to deliver your message, position yourself as a thought leader, and introduce new products, techniques and strategies to the market.

PLEASE ENTER YOUR EMAIL TO JOIN FOR FREE

Already an IQPC Community Member?Sign in Here or Forgot Password
Sign up now and get FREE access to our extensive library of reports, infographics, whitepapers, webinars and online events from the world’s foremost thought leaders.

We respect your privacy, by clicking ‘SUBSCRIBE’ you agree to receive our e-newsletter, including information on Podcasts, Webinars, event discounts and online learning opportunities. For further information on how we process and monitor your personal data click here. You can unsubscribe at anytime.